Panitumumab is the first fully human anti-epidermal growth factor receptor (EGFR) antibody approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer (mCRC), the third most common cancer found in both men and women in the U.S., and is the second leading cause of cancer deaths.[1] [2] Approximately 1.2 million cases of colorectal cancer are expected to occur globally [3]

Trial DesignASPECCT is a global, randomized, parallel assignment, open-label, Phase III non-inferiority trial designed to compare the effect of panitumumab versus cetuximab on overall survival for monotherapy treatment of chemorefractory mCRC in 1,010 patients with wild-type KRAS tumors (primary endpoint). Secondary endpoints included safety, patient reported outcomes, progression-free survival, time to response, time to treatment failure and duration of response.

Patients were randomized in a 1:1 ratio to receive 6 mg/kg of intravenous panitumumab every 14 days or 400 mg/m2 of an initial dose of intravenous cetuximab followed by 250 mg/m2 of intravenous cetuximab every seven days.

Adverse eventsOverall, the relative adverse event profiles were as anticipated for each of the anti-EGFR therapies studied, including known events such as rash, diarrhea and hypomagnesemia.

In Europe, the ASPECCT trial is a Specific Obligation for panitumumab as part of the European Medicine Agency's (EMA) conditional marketing authorization. Detailed safety and efficacy data will be submitted for presentation at an upcoming medical meeting later this year.